Biden’s FDA pick Califf vows to reform accelerated approvals to win a key senator’s support

WASHINGTON — President Biden’s pick to lead the Food and Drug Administration promised a key senator that he will crack down on drug companies abusing the so-called accelerated approval pathway within a month of his confirmation.

Robert Califf met with Sen. Ron Wyden (D-Ore.), the chair of the Senate Finance Committee, last week, STAT first reported. In a new letter made public Friday, Wyden provides a clear summation of his discussion with the nominee.

Califf promised not to halt the use of the accelerated approval pathway, which allows the FDA to approve drugs without clear evidence they help patients live longer, but instead to discipline drug makers that get drugs approved via the shortcut pathway and then drag their feet on the follow-up clinical trials mandated by the FDA.

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